ABOUT THIS STUDY
- Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.
- At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
- Planning to remain in western New York (NY) during the study period
- Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
- English speaker
- To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.
- Use of other tobacco products, including e-cigarettes, in past 7 days
- Use of smoking cessation medication, including nicotine replacement therapy, in the
past 14 days
- Prior allergy/hypersensitivity to varenicline
- Pregnant or breast-feeding
- Substance use:
- Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and
warranting treatment; for those with scores between 8 and 15, the investigators
will advise reducing drinking).
- Medical treatment for substance use in past 3 months, including Suboxone
(buprenorphine) and methadone (at phone screen)
- Using a combination of the National Institute on Drug Abuse (NIDA) modified
ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both
- Cannabis: ASSIST=27+ (tox screen not used)
- Cocaine: ASSIST=7+ OR positive tox screen
- Methamphetamine: ASSIST=7+ OR positive tox screen
- Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
- Prescription stimulants: With prescription, ASSIST 27+; Without
prescription, ASSIST 7+
- Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is
for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive
(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems.
clinicaltrials.gov edited 12/18/18)
- Antipsychotic medications
- Lifetime history of schizophrenia or bipolar disorder
- Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at
- Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following
are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner
et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating
(Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is >
2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal
Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide
preparatory acts or behavior on the C-SSRS).
- Any medical condition, illness, disorder or concomitant medication that compromises
participant safety or treatment, as determined by the Principal Investigator and/or
- Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.
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